ERAS-601 for Chordoma

Recruiting at 6 trial locations

Overseen By Robert Maki, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: CYP3A4 inducers

Disqualifiers: SHP2 inhibitor, PTPN11 mutations, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 year

11 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ERAS-601 to determine its safety and effectiveness for people with chordoma, a rare type of bone cancer, particularly when the cancer worsens. Researchers aim to assess whether ERAS-601 can manage the condition without causing excessive side effects. Suitable participants have confirmed chordoma that has not responded well to other treatments and continues to progress. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but you cannot be on another treatment that may impact the trial's outcome within 4 weeks of starting ERAS-601. Also, you should not have had certain therapies or strong CYP3A4 inhibitors recently.

Is there any evidence suggesting that ERAS-601 is likely to be safe for humans?

Earlier studies tested ERAS-601 for safety in people with chordoma, a cancer affecting the bones at the base of the skull and spine. Research has shown that ERAS-601 is generally well-tolerated, with many patients experiencing only mild side effects. Reports of more serious side effects exist but are less common.

This trial is in the early stages (Phase 1 and 2), focusing primarily on understanding the safety of ERAS-601. Researchers closely monitor participants' responses to ensure the treatment remains safe. The progression to these trial phases indicates that ERAS-601 has shown enough promise in earlier tests to warrant further study. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for chordoma?

Most treatments for chordoma, such as surgery and radiation, focus on removing or shrinking the tumor. However, ERAS-601 works differently by targeting specific molecular pathways that drive tumor growth, potentially slowing or stopping the disease at a more fundamental level. This targeted approach could mean fewer side effects and more effective control of the cancer. Researchers are excited about ERAS-601 because it offers a new way to tackle chordoma, which has limited treatment options and can be challenging to treat with conventional methods.

What evidence suggests that ERAS-601 might be an effective treatment for chordoma?

Research has shown that ERAS-601 may help treat advanced chordoma, a type of cancer. In one study, out of 13 people with chordoma, one person's tumor shrank. Another study found that out of 11 patients treated, two showed some improvement, though details were not provided. These early results suggest that ERAS-601 might reduce tumor size in some chordoma patients, but more research is needed to determine its overall effectiveness. ^{1 2 3 6 7}

Who Is on the Research Team?

Mrinal Gounder, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals with advanced and progressing chordoma, a type of bone cancer. Specific eligibility criteria are not provided, but typically participants must meet certain health conditions and agree to follow study procedures.

Inclusion Criteria

Screening laboratory values meeting specified criteria

Willing to comply with all protocol required visits, assessments, and procedures

Willing to participate in patient interviews for quality-of-life assessment and complete patient reported outcomes (PRO) questionnaires

Exclusion Criteria

Currently receiving another treatment within 4 weeks of the first dose of ERAS-601 that may impact the outcome of this trial

I haven't had cancer treatment in the last 3 weeks or 5 half-lives, whichever is shorter.

Pregnant, breastfeeding, expecting to conceive or father children within the projected duration of the trial

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ERAS-601 40mg BID, 3-weeks on 1-week off, as monotherapy

1 year

Monthly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• ERAS-601

Trial Overview

The study is testing the safety and effectiveness of ERAS-601 as a treatment for chordoma. The goal is to determine if it causes few or mild side effects while helping those with this condition.

How Is the Trial Designed?

Group I: ERAS-601 Experimental Treatment 1 Intervention

All patients on the single-arm Phase 1b study will take ERAS-601 40mg BID, 3-weeks on 1-week off (3/1), as monotherapy. Each treatment cycle consists of a 4-week (28-day) treatment period.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Citations

1.

chordomafoundation.org

chordomafoundation.org/latest-updates/promising-results-eras-601/

Promising results emerge from clinical trial testing ERAS- ...

Of the 13 chordoma participants who enrolled on the trial, 1 patient achieved a partial response by RECIST criteria (meaning the tumor shrank by ...

2.

cancer.gov

cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2025-03434

ERAS-601 for the Treatment of Advanced or Progressing ...

This phase Ib/II trial studies how well ERAS-601 works in treating patients with chordoma that may have spread from where it first started to nearby tissue, ...

3.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.11522

A phase 1 study of ERAS-601 as a monotherapy ...

Results: As of 31 Oct 2023, a total of 11 pts with previously treated advanced or metastatic chordoma received ERAS-601. Two pts received ERAS- ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06957327?cond=Chordoma%20OR%20%22chordoma%20(disease)%22%20OR%20%22%20chordoma,%20malignant%22%20OR%20%22%20notochordal%20sarcoma%22%20OR%20%22%20notochordoma%22&aggFilters=status:not%20rec&viewType=Table&rank=3

A Study of ERAS-601 in People With Chordoma

The researchers are doing this study is to find out whether ERAS-601 is a safe and effective treatment that causes few or mild side effects in people with ...

5.

chordomafoundation.org

chordomafoundation.org/latest-updates/eras601-trial/

New clinical trial opens testing ERAS-601

New chordoma clinical trial launches along with expanded support for patients. The trial aims to test whether two drugs, pemetrexed and pembrolizumab, could ...

6.

trialfinder.panfoundation.org

trialfinder.panfoundation.org/en-US/trial/listing/605237

A Study of ERAS-601 in People With Chordoma

The researchers are doing this study is to find out whether ERAS-601 is a safe and effective treatment that causes few or mild side effects ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04670679

A Dose Escalation/Expansion Study of ERAS-601 in ...

To evaluate the safety and tolerability of escalating doses of ERAS-601 when administered as a monotherapy and in combination with other cancer therapies in ...